BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.25MM PL REDUCTION WIRE/THRDD TIP W/LRG STOP/150MM-STERILE

    MDR report key: 10958373 · Received December 7, 2020

    Report

    Report Number
    8030965-2020-09399
    Event Type
    Injury
    Date Received
    December 7, 2020
    Report Date
    November 13, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    07611819400085
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. INVESTIGATION SUMMARY INVESTIGATION SITE: CQ ZUCHWIL, SELECTED FLOW: DAMAGED: VISUAL / EXAMPLES: DEFORMED/BENT/CRACKED/BROKEN. VISUAL INSPECTION: THE RECEIVED REDUCTION WIRE IS BROKEN APART AT THE CROSSOVER FROM THE LARGE STOP TO THE SHAFT. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY, AND HAS THE TYPICAL VIEW OF A FORCED RUPTURE. THERE ARE IN DIFFERENT AREAS OF THE SHAFT STRONG STRESS MARKS VISIBLE. DIMENSIONAL INSPECTION: CHECKED DIMENSIONS WITH CALIPER 3-01-20766 PER DRAWING: OUTER SHAFT DIAMETER BELOW THE GROOVE , SPECIFICATION / MEASURED: = PASS . DOCUMENT/SPECIFICATION REVIEW: DRAWING WAS REVIEWED TO VERIFY THE RELEVANT DIMENSION AND THE MATERIAL SPECIFICATION. THE REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT WITH 316L STAINLESS STEEL THE CORRECT MATERIAL WAS USED AND THAT THE MATERIAL WAS ACCORDING TO ISO NORM 5832-1 FOR IMPLANTS FOR SURGERY AS REQUIRED. THE LOT IN QUESTION WAS MANUFACTURED IN JULY 2017 WITH A LOT SIZE OF (B)(4) PIECES AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT COMBINATION. INVESTIGATION CONCLUSION: THE COMPLAINT IS RATED AS CONFIRMED AS THE REDUCTION WIRE IS BROKEN AS COMPLAINED. DURING THE PERFORMED EVALUATION NO MANUFACTURING RELATED ISSUE COULD BE DETECTED. BASED ON THE APPEARANCE OF THE WIRE, ESPECIALLY WITH THE STRESS MARKS AT THE SHAFT, WE HAVE TO ASSUME THAT A MECHANICAL OVERLOAD BY TOO MUCH APPLIED FORCE DURING THE INSERTION DID LEAD TO THE BREAKAGE OF THIS DEVICE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT PART: 02.111.501.01S, LOT: L489990, MANUFACTURING SITE: BALSTHAL, RELEASE TO WAREHOUSE DATE: JULY 26, 2017, EXPIRY DATE: JULY 1, 2027. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. E1: REPORTERS STATE: (B)(6). H11: G1. MANUFACTURING SITE NAME PROVIDED FOR REPORTING. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT DURING A DISTAL RADIUS OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE USING THE 7 HOLE PLATE, THERE WAS A DELAY TO THE PROCEDURE AS THE THREADED BALL AND TIP OF THE REDUCTION INSTRUMENT HAD TO BE REMOVED MANUALLY FROM THE BONE WITH PLIERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNK - PLIERS: (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: 2). THIS REPORT IS FOR ONE (1) 1.25MM PL REDUCTION WIRE/THRDD TIP W/LRG STOP/150MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423954 1.25MM PL REDUCTION WIRE/THRDD TIP W/LRG STOP/150MM-STERILE MISC ORTHO SURGICAL INSTR LXH SYNTHES GMBH L489990 07611819400085

    Patients

    Seq Age Sex Outcome Treatment
    1 PLATE REDUCTION WIRE Ø1.25 W/LARGE STOP| UNK - PLIERS| UNK - PLIERS| UNK - PLIERS| UNK - PLIERS| UNK - PLIERS| UNK - PLIERS